Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

The substance is poorly water soluble, is not readily biodegradable and is unsuitable for experimental assessment of hydrolysis because the test item is a complex, surface active, UVCB where the components exist as ion pairs. Evidence from screening studies and data disseminated by ECHA following REACH registration of the environmentally relevant UVCB component [EC 273-279-1] indicates that the substance may persist in the aquatic environment.

Bioaccumulation

The test item is a complex UVCB for which Log Kow has been predicted to be 5.14 for the environmentally relevant organic amine component [EC 273-279-1]. This value is above 4.5 and it is not possible to conclude solely on the basis of Log Pow that aquatic BCF will be below the 2000 L/kg threshold where bioaccumulation becomes a concern. However, evidence for low bioaccumulation potential is provided by EPISuite BCFBAF v3.0, which predicts BCF as 48.58 L/kg wet weight based on SMILES notation for the component. As a result, the UVCB test item is not expected to bioaccumulate following exposure to substance or its constituents and, in accordance with REACH Annex IX, section 9.3.2, column 2, experimental investigation is unnecessary (see ECHA Guidance on Information requirements and chemical safety assessment Chapter R11: PBT assessment (Version 2.0; November 2014).

Toxicity

Based on available evidence, and in accordance with Regulation (EC) No. 1272/2008, the substance does not meet the criteria for classification as a carcinogen (category 1A or 1B) or germ cell mutagen (category 1A, 1B or 2). Adverse effects observed during investigation of repeated dose toxicity and reproductive/developmental toxicity via the oral route are not considered relevant to humans and, as a result, the substance does not meet the criteria for classification for specific target organ toxicity (STOT RE 1 or STOT RE 2). With respect to the environment, short-term results required by present regulatory obligations lead to classification of the UVCB substance for acute and long-term aquatic toxicity. However, these data are considered screening information and may only be used to determine that the substance may fulfil the T criterion (see ECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 2.0; November 2014)).

Likely routes of exposure:

Human exposure via the dermal route plus release to the environment via waste water.

Categories Display